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临床试验/NCT05240053
NCT05240053已完成不适用

Enhanced Recovery Program After Laparoscopic Colorectal Surgery During The Era Of COVID-19 : A Randomized Controlled Trial

Zagazig University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
incidence of complications after enhanced recovery program

研究概览

简要总结

The investigators included all patients who were subjected to laparoscopic colorectal surgery at investigators' center between ( December 2019 to December 2021) for benign & malignant conditions. sample size was 50 patients , divided into 2 equal groups . Group 1: included 25 patients who were subjected to enhance recovery program after laparoscopic colorectal surgery . Group 2: included 25 patients who were subjected to traditional way - nothing by mouth until the resolution of ileus, then a fluid diet, followed by a regular diet after laparoscopic colorectal surgery.

详细描述

The investigators included all patients who were subjected to laparoscopic colorectal surgery at investigators' center between ( December 2019 to December 2021) for benign & malignant conditions. The study was approved by the research and Ethics committee of our university and performed in accordance with the code of ethics of the world medical association (Declaration of Helsinki) for studies involving humans. A written informed consent was obtained from all participants.

Sample size The sample size was calculated using open Epi program . sample size was 50 patients , divided into 2 equal groups . Group 1: included 25 patients who were subjected to enhance recovery program after laparoscopic colorectal surgery . Group 2: included 25 patients who were subjected to traditional way - nothing by mouth until the resolution of ileus, then a fluid diet, followed by a regular diet after laparoscopic colorectal surgery.

Perioperative measures:

In this prospective randomized controlled trials , all patients were subjected to the followings: patients were selected by randomization method , Full history taking , Complete physical examination , laboratory investigations ( complete blood picture , liver and kidney functions , coagulation profile , tumor marker tests, serum electrolytes) , patients were assessed radio- logically by barium enema, abdominal ultrasound ,pelvic and abdominal CT, bone survey and chest X-ray in addition to colonoscopy and biopsy for diagnosis of colorectal cancer, all cases were well prepared by correction of electrolytes and acid-base disturbance , all cases were subjected to colonic preparation.

Surgical techniques :

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with age ranged from 20-75 years
  • patients who had no contraindication for laparoscopic surgery
  • good general condition with American society of anesthesiology (ASA) I & II

排除标准

  • patients who had bad general condition (ASA ≥3)
  • patients with age above 75 years
  • patients with uncompensated cardiopulmonary disease , immunological disorders ,immunosuppressive therapy for any cause.
  • Patients who had chronic liver disease
  • patients who underwent emergency laparotomy and had a stoma created for them or those with metastasis

结局指标

主要结局

incidence of complications after enhanced recovery program

时间窗: within one week after the surgery

incidence of complications after after enhanced recovery program

次要结局

  • incidence of mortality after enhanced recovery program(within one month after the surgery)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Said Mohamed Said Abdou Negm

lecturer of general surgery

Zagazig University

研究点 (2)

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